Cardiac Implantable Pulse Generator

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Generator, Pulse, Cardiac, Implantable

510(k) Number

K780420 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Slimline Unipolar Endocardial Pacing Lead, 030-438

  Class III

  FDA 510(k) K865098 Active Cleared 18 Aug 1987

• Model 030-437 Implant Electrode

  Class III

  FDA 510(k) K870610 Active Cleared 20 Mar 1987

• Sterile Packaging

  Class III

  FDA 510(k) K810410 Active Cleared 5 Mar 1981

• Implantable Programmable Bipolar Cardiac (K800573)

  Class III

  FDA 510(k) K800573 Active Cleared 25 Mar 1980

• Laserpor Ap Atrial Endocard. Electr. Ld.

  Class III

  FDA 510(k) K820121 Active Cleared 12 Feb 1982

• Electrode, Model 030-324

  Class II

  FDA 510(k) K781822 Active Cleared 8 Feb 1979

See all devices from Telectronics, Inc. →

• What is the primary purpose of this device in clinical practice?

  This device is a cardiac implantable pulse generator designed to regulate abnormal heart rhythms by delivering electrical impulses to the heart muscle. It is specifically intended for patients with bradycardia or conduction disorders to maintain proper cardiac pacing and ensure normal heart function.

• Is this device intended for single-use or can it be reused?

  The device is supplied sterile for single-patient application, meaning it is intended to be used once per patient and not reused. Sterility and single-use compliance are critical for implantable devices to prevent infection and ensure patient safety.

• How should this device be stored and handled to maintain its integrity?

  Since it is sterile and intended for implantable use, storage and handling must follow strict sterile medical device protocols. This includes keeping it in its original packaging until ready for use and adhering to manufacturer guidelines to prevent contamination or damage.

• What regulatory pathway did this device undergo to gain market authorization?

  This device received FDA 510(k) clearance under the Traditional pathway, demonstrating substantial equivalence to predicate devices. It is classified under FDA classification III (DXY) for pacemaker systems and is governed by regulation number 870.3610.

• What types of patients is this device intended to support?

  This device is intended for patients with bradycardia or conduction disorders, where the heart’s natural electrical system fails to maintain an adequate heart rate or rhythm. It provides pacing support to restore normal cardiac function.